Diversity & Inclusion in Clinical Trials
Maßnahmenpläne zur Unterstützung der Diversität
We can help you meet regulatory requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.
Proven experience
Meet Diversity Action Plan requirements with the team that has completed ~15 % of the drug products and medical device plans submitted to the FDA thus far.
Expert support
Advance your negotiations with regulators for concurrence on your Diversity Action Plan.
Powerful technology
Leverage in-study diversity insights with the Fortrea Diversity and Inclusion Study Insights Dashboard.
Leading the way on Diversity Action Plans
On June 26, 2024, the U.S. FDA’s draft guidance on improving diversity was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance is now open for comments through September 26, 2024. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.
The Fortrea Regulatory Strategy Consulting team closely tracks the U.S. regulatory landscape to understand how other regulatory agencies (e.g., EMA and MHRA) are working to meaningfully improve the diversity of clinical trial participants in global studies.
Creating solutions beyond the plan
We write and support the implementation of Diversity Action Plans that set diversity goals and help eliminate gaps in participation. Throughout your clinical development, we are an extension of your team to support your diversity goals and inclusion practices. With our unique combination of consulting services, mobile and digital capabilities, strong investigator site network and our innovative Diversity and Inclusion Insights Dashboard, we're ready to enable greater patient access and improve healthcare for all.
Upgrade your diversity planning with real-world data
Our experts help you set realistic diversity goals. Der Plan zur Förderung der Diversität beginnt mit einer umfassenden epidemiologischen Bewertung, um mithilfe von Realdaten und Fachliteratur die Prävalenz einer Erkrankung in der Zielgruppe zu ermitteln. Our experts then consult to understand the requirements, applicability to your program and map out a path forward.
Locate, attract and retain—bringing your plan to life
With access to multiple data platforms, our Site Advisory Board and technology-enabled solutions, our team identifies where diverse patients are located and implements strategies to attract and retain them.
Supporting regulatory interactions
Ihr Maßnahmenplan zur Förderung der Diversität muss im Anschluss kommuniziert werden. Wir erfassen im Rahmen einer Studie und eines Programms Kennzahlen, entwerfen Berichte und unterstützen Sie bei Bedarf bei der Kommunikation mit Behörden.
Das „Fortrea Diversity & Inclusion Study Insights Dashboard“
Leverage powerful, in-study diversity insights and end-of-study reporting
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In-study enrollment monitoring
To help ensure your study is reflective of a real-world population, we provide in-study enrollment monitoring of the predefined demographic and non-demographic characteristics of participants. From study startup through conduct and closeout, our proprietary dashboard can:
- Analyse von Daten auf Grundlage von Rasse, Alter, Geschlecht und ethnischer Herkunft, um gruppenspezifische Merkmale zu identifizieren
- Bewertung der Sicherheit und Wirksamkeit des im Rahmen der Studie untersuchten Wirkstoffs auf Grundlage spezieller Parameter
- Überprüfung von Beendigungen der Teilnahme und Abgängen aufgrund einer Teilnahme an anderen Studien in Bezug auf unterschiedliche Kohorten/Einrichtungen, um Ihre Strategie zur Patientenbindung zu stärken
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A real-time view of current trends
With powerful, in-study diversity data from the dashboard, you’ll have a real-time view of current trends in your trial so you can:
- Treffen informierter Entscheidungen, um die Effektivität Ihres Maßnahmenplans zur Förderung der Diversität zu bewerten
- Anpassung Ihrer Strategien zur Patientenanmeldung und -bindung
- Umsetzung korrigierender Maßnahmen
- Erstellung von Berichten zur Unterstützung der laufenden Verwaltungstätigkeit und Einreichung von Anträgen